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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K210118
Device Name INFRARED BODY THERMOMETER (Model: YK-001)
Applicant
Longnan Renzhong Medical Equipment Co., Ltd.
Information Industry Technology City,
Longnan Economic Development Zone, Longnan
Ganzhou,  CN
Applicant Contact Liangping Liao
Correspondent
Sgs-Cstc Standards Technical Services Co., Ltd.
198 Kezhu Rd., Scientech Park
Guangzhou Economic & Technology Development
Guangzhou,  CN
Correspondent Contact Iris Fung
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/19/2021
Decision Date 09/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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